Annexin Pharmaceuticals announced that all patients in the first dose group with the lowest dose have now completed treatment in the company's clinical phase 2 study in patients with retinal vein occlusion (RVO) with the investigational drug candidate ANXV. No limiting treatment-related side effects have been reported and the company has received recommendation to proceed with treatment of patients in the next dose group. An expected accelerated recruitment rate means that last patient in is planned to the first quarter of 2024.

All six planned patients have now completed treatment in the phase 2 study's first patient group (cohort) where the patients were treated at the lowest dose level, 2 mg/day, for five days. No limiting side effects have been observed in the first cohort and after the recommendation by an independent Safety Review Committee, which evaluate the study based on safety, among other things, the first patient has now been treated in the second cohort of the study, where up to ten patients are planned to be treated with the higher dose, 4 mg/day, for five day. After two patients have been treated with the higher dose, a safety evaluation will be performed before the remaining patients can be enrolled.

The company intends to continuously update the market on any efficacy signals, or any treatment-related side effects, as clinical data and other patient information have been verified and assessed by experts. In August 2023, Annexin reported promising efficacy signals in two out of four patients treated with ANXV in the ongoing Phase 2 study. The positive findings warranted, among other things, extended patient follow-up and removal of the placebo group in the study as the ANXV treatment did not give rise to any serious treatment-related side effects.

Annexin's Phase 2 clinical trial includes patients who have recently received their RVO diagnosis, but who have not been treated with the standard anti-VEGF therapy. It is an open-label study in which patients receive ANXV followed by anti-VEGF (if needed) and followed for up to four months with examinations to evaluate safety, tolerability and any signals of efficacy related to ANXV. The company plans to include up to 16 patients, of which six patients have been treated at the lower dose level, 2 mg/day, and up to ten patients are intended to be treated at the higher dose level, 4 mg/day.